Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Tre… (NCT06088290) | Clinical Trial Compass
RecruitingPhase 3
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)
United States450 participantsStarted 2023-09-21
Plain-language summary
The primary objective of this phase III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntary signed and dated written informed consent of the participants obtained before any study-specific procedure.
✓. Age ≥ 18 years.
✓. Histologically confirmed diagnosis of metastatic LMS, in participants not candidates for curative resection.
✓. Radiologically measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
✓. No previous systemic therapy for metastatic disease (i.e., first-line setting) and no previous anthracyclines. Note: prior chemotherapy (without anthracycline) in the context of adjuvant or neoadjuvant therapy is allowed. Prior line/s of hormone therapy in the adjuvant/metastatic setting are also allowed.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
✓. Adequate hematological, renal, metabolic and hepatic function:
✓. Hemoglobin ≥ 9.0 g/dL (participants may have received prior red blood cell \[Red Blood Cell\] transfusion); absolute neutrophil count (ANC) ≥ 2.0 x 10\^9/L, and platelet count
Exclusion criteria
✕. Prior treatment with anthracyclines, lurbinectedin or trabectedin.
✕. Known low grade leiomyosarcoma (i.e., grade I).
✕. Known hypersensitivity to any of the components of the IV formulation of lurbinectedin or doxorubicin.
✕. History of cardiac disease: myocardial infarction or angina within the year prior to enrollment; severe vascular disease; or symptomatic arrhythmia despite ongoing treatment.
✕. Participants with any immunodeficiency, including those known to be infected by human immunodeficiency virus (HIV).
✕. Known chronic active hepatitis or cirrhosis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR.